“It’s in line,” Dr. Mahmoud says of the change, “with the expanding applications of this in different disciplines where patients are self-collecting the samples.”
An existing requirement, COM.06300 Specimen Rejection Criteria, which requires the lab to define and follow its criteria, has one new addition that says a self-collected vaginal specimen is appropriate for HPV testing but not for cytology testing. “It’s a reminder,” Dr. Gagnon says, “that self-collection specimens have not been FDA approved for cytology methods.” Self-collection can be convenient and helpful but applies only to HPV, he says. “The Pap smear still requires a cervical sampling.”
HEM.38360/LSV.38706 Pneumatic Tube Transport–Platelets is new and requires the laboratory to ensure that blood specimens for platelet aggregation or other platelet function testing are not negatively impacted by pneumatic tube transport. Members of the CAP Hemostasis and Thrombosis Committee recommended this requirement be added.
“When you send specimens through the pneumatic tube, they might be subjected to certain physical forces that might impact the platelet function testing. We allow the laboratories to do that,” Dr. Mahmoud says, “provided the manufacturer allows it.” If the manufacturer does not allow pneumatic tube system transport, the laboratory has to validate the tube transport for each platelet function test method, he says.
“Typically,” he adds, “if the manufacturer does not allow it, you shouldn’t do it.”
More automated platelet function testing systems have become available for purchase in recent years, Dr. Gagnon notes, and thus “more and more labs are doing this as a routine study.” The requirement may be an “eye-opener” for some, he says.
Also new to the 2025 checklist edition is a section consisting of two requirements for nonurine body fluid crystal analysis, recommended by members of the CAP Hematology/Clinical Microscopy Committee. -HEM.35651 Crystal Morphology Assessment requires crystal identification to be performed using a light and polarized microscope to accurately assess the presence and morphology of body fluid (for example, synovial fluid) crystals.
The requirement lists the following suggested methods: examining both wet and stained cytocentrifuge preparations; lowering the condenser to improve contrast and improve the potential to see crystals by brightfield microscopy; using polarization microscopy; scanning the slide using a 10× objective and using higher power (40×, 100×) for definitive identification; and distinguishing dust, scratches, and debris from pathologic crystals.
HEM.35652 Criteria for Body Fluid Crystal Review requires the laboratory to have defined criteria and follow a process for review of specified findings on cytocentrifuged slides and/or wet mount slides by the pathologist, consultant, supervisor, or other technologist qualified in characterization of crystal morphology and birefringence polarized microscopy.
“This crystal analysis section for body fluids was not previously well addressed,” Dr. Gagnon says, “which is why these requirements were developed” and incorporated into the new checklist edition. “This section requires the laboratory to document the process a little more clearly, and it gives the inspector checklist requirements with granularity and specificity to refer to when they’re evaluating the process a lab uses for this type of testing.”
The same requirements are in other checklists as URN.30900/LSV.43726 Crystal Morphology Assessment—Non-urine Body Fluids and URN.30925/LSV.43729 Criteria for Body Fluid Crystal Review—Non-urine Body Fluids.
Dr. Gagnon describes the changes to the 2025 checklist edition as “fine-tuning and incremental upgrades.” And Dr. Mahmoud paints the broad picture: “We are always trying to add more value.”
“When laboratories are compliant with all the requirements,” Dr. Mahmoud says, “they are focused on patient safety and better patient care. That’s the bottom line.”
Valerie Neff Newitt is a writer in Audubon, Pa.